Director Of Regulatory Affairs, New Ventures

Director of Regulatory Affairs, New Ventures About the Company Top-tier medical device company

Industry
Medical Devices

Type
Privately Held








About the Role The Company is seeking a Director of Regulatory Affairs for New Ventures.
The successful candidate will be responsible for developing and implementing comprehensive regulatory strategies and submissions to secure marketing approvals for innovative products.
This role involves close collaboration with internal and external partners, including serving as a strategic liaison with regulatory authorities.
The Director will also be tasked with managing a team, if applicable, and ensuring that all regulatory activities are in compliance with relevant regulations and company policies.
Applicants for the Director of Regulatory Affairs, New Ventures position at the company should have a BS degree in a relevant field and at least 10 years' experience in regulatory affairs, with a preference for those with a background in pharmaceutical and medical device/combination product development.
The role requires a deep understanding of FDA processes for various product types, the ability to write clear regulatory strategies and submissions, and experience in cross-functional collaboration.
The ideal candidate will have a proven track record in managing regulatory submissions for novel, Class II, and Class III medical devices, as well as experience in communication with health authorities.
Strong leadership, analytical, and mentoring skills are also essential for this position.

Hiring Manager Title
VP of Global Regulatory Affairs



Travel Percent
Less than 10%

Functions Medical Care/Hospital Administration